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Diagnostic Yield of 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions

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ClinicalTrials.gov Identifier: NCT02920944
Recruitment Status : Completed
First Posted : September 30, 2016
Last Update Posted : October 3, 2017
Sponsor:
Collaborator:
Seoul St. Mary's Hospital
Information provided by (Responsible Party):
Seung Bae Yoon, Seoul St. Mary's Hospital

Brief Summary:
This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Device: EUS-FNB with 20 gauge ProCore needle Device: EUS-FNB with 22 gauge ProCore needle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
Study Start Date : July 2016
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: EUS-FNB with 20-gauge
EUS-FNB with 20-gauge procore needle
Device: EUS-FNB with 20 gauge ProCore needle
EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)

Active Comparator: EUS-FNB with 22-gauge
EUS-FNB with 22-gauge procore needle
Device: EUS-FNB with 22 gauge ProCore needle
EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)




Primary Outcome Measures :
  1. single diagnostic yield of the histologic core [ Time Frame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy ]

Secondary Outcome Measures :
  1. total diagnostic yield of the histologic core [ Time Frame: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.

Exclusion Criteria:

  • cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920944


Locations
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Korea, Republic of
The Catholic University of Korea
Seoul, No State, Korea, Republic of, 06591
Sponsors and Collaborators
Seung Bae Yoon
Seoul St. Mary's Hospital
Investigators
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Study Director: In Seok Lee, MD The Catholic University of Korea

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Responsible Party: Seung Bae Yoon, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02920944     History of Changes
Other Study ID Numbers: EUS 20 gauge
First Posted: September 30, 2016    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases